Maxxi Position Sensor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Neurovirtual USA, Inc. Eduardo Faria CEO 3303 W Commercial Blvd. Suite #100 Fort Lauderdale, Florida 33309 ## Re: K191492 Trade/Device Name: Maxxi Position Sensor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, OLV Dated: January 28, 2020 Received: February 3, 2020 Dear Eduardo Faria: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191492 Device Name Maxxi Position Sensor Indications for Use (Describe) The Maxxi Position Sensor is intended for use with the BWMini polysomnograph system, to acquire the body position of adult patients during sleep studies. The Sensor produces signals for five positions: supine, prone, left and right. It is intended for use in research, home sleep studies, ambulatory, and clinical environments. Type of Use (Select one or both, as applicable) | <div> <span style="font-size: 10pt"> <span style="font-family: Wingdings">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt"> <span style="font-family: Wingdings">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The "O" in "NEUROVIRTUAL" is colored orange, matching the waveform graphic. ## 510(k) SUMMARY - A) Submitter's Name: Neurovirtual USA, Inc. #### Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006125362 - B) Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL - 33309 - C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429 - D) Contact Person: Eduardo J. Faria - E) Revision Date: March 24, 2020 - F) Classification Name: Common / Usual Name: Body Position Sensor Proprietary Name: Maxxi Position Sensor Product code: GWQ, OLV Class: Class II Regulation: 21 CFR 882.1400 #### G) Device Description The Maxxi Position Sensor is a sensor that attaches to either around chest or abdominal belts using velcro tapes- so no additional belts or attachment systems are needed. The sensor features a fully encapsulated active element for troublefree cleaning. The Maxxi Position Sensor produces a clear and reliable signal for five positions: Upright, supine, prone, left and right. It comes with 7ft long cable for a convenient connection with the PSG device recorder. #### H) Substantial Equivalence: The Maxxi Position Sensor is equivalent with the following products: | 510(k) Number | Model | Company | |---------------|-----------------------------|-----------------------| | K131335 | BWMINI | NEUROVIRTUAL USA INC. | | K981969 | ULTIMA BODY POSITION SENSOR | BRAEBON MEDICAL CORP. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue, sans-serif font. The "O" in "NEUROVIRTUAL" is replaced with a solid orange circle. #### 1. Indications for Use: | Indications for Use Comparison | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Neurovirtual<br>Maxxi Position Sensor | BRAEBON MEDICAL CORP.<br>Ultima Body Position Sensor | Neurovirtual<br>BWMini | | The Maxxi Position<br>Sensor is intended for<br>use with the BWMini<br>polysomnograph system,<br>to acquire the body<br>position of adult patients<br>during sleep studies. The<br>Sensor produces signals<br>for five positions:<br>standing/sitting, supine,<br>prone, left and right. It is<br>intended for use in<br>research, home sleep<br>studies, ambulatory, and<br>clinical environments. | The BRAEBON MEDICAL<br>CORPORATION Ultima Body<br>Position Sensor™ is intended for<br>use during sleep disorder studies<br>as an indicator of body position.<br>The sensor uses a three-volt<br>lithium battery and plugs directly<br>into either a DC amplifier or<br>multiplexer.<br><br>The target population of the<br>Ultima Body Position Sensor is all<br>children and adult patients who<br>are screened during sleep<br>disorder studies. The majority of<br>the screenings occur at a sleep<br>laboratory although the sensor<br>can also be used in home<br>studies.<br><br>The Ultima Body Position Sensor<br>is intended for use only by or on<br>the order of a physician. | BWMini is an electroencephalograph,<br>which is a device used to measure and<br>record the electrical activity of the<br>patient's brain obtained by placing two<br>or more electrodes on the head.<br><br>BWMini is multi-channel (up to 32<br>channels) system designed for<br>Electroencephalograph (EEG),<br>Polysomnography (PSG) and Home<br>Sleep Testing (HST) recording<br>application, in research, home sleep<br>studies, ambulatory and clinical<br>environments.<br><br>The BWMini does not make any<br>judgment of normality or abnormality<br>of the displayed signals or the results<br>of an analysis. In no way are any of<br>the functions represented as being in<br>and of themselves diagnostic. | #### 2. Technological Characteristics Comparison: The predicate devices used to establish substantial equivalence for the Maxxi Position Sensor is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Maxxi Position Sensor to each of the predicate devices stratified by functional modality. | Specifications Comparison | | | | | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Device Brand<br>and Common<br>Name | Neurovirtual<br>Maxxi Position<br>Sensor | Neurovirtual<br>BWMini | BRAEBON<br>MEDICAL CORP.<br>Ultima Body<br>Position Sensor | Comments | | 510(k)<br>Number | K191492 | K131335 | K923033 | NA | | Classification | GWQ, OLV | GWQ, OLV | LEL | The predicate BWMini<br>is classified as GWQ | | Regulation # | 21 CFR 882.1400 | 21 CFR 882.1400 | 21 CFR 882.5050 | is classified as GWQ | | Classification<br>Name | Electroencephalogr<br>aph used for<br>polysomnography<br>or sleep studies | Electroencephalogr<br>aph used for<br>polysomnography<br>or sleep studies | Device, Sleep<br>Assessment | because it is a full<br>polysomnograph<br>recording device that<br>includes an internal<br>body position sensor<br>with same | | | | | | technological<br>characteristics as the<br>subject device. This<br>information may not<br>publicly available. | | Patient<br>Population | Adult patient | Adult patient | Adult patient | Identical | | Indented<br>Environment | The intended<br>environments are<br>research, home<br>sleep studies,<br>ambulatory, and<br>clinical<br>environments. It<br>is intended for<br>adult patients. | The intended<br>environments are<br>research, home<br>sleep studies,<br>ambulatory, and<br>clinical<br>environments. It is<br>intended for adult<br>patients. | The intended<br>environments are<br>research, home<br>sleep studies,<br>ambulatory, and<br>clinical<br>environments. It is<br>intended for adult<br>patients. | Identical | | Prescription<br>Use | YES | YES | YES | Identical | | Sensor<br>Material | Plastic ABS<br>enclosure<br>Electronic<br>components<br>Printed Circuit<br>board | Plastic ABS<br>enclosure<br>Electronic<br>components<br>Printed Circuit<br>board | Plastic ABS<br>enclosure<br>Electronic<br>components<br>Printed Circuit<br>board | Equivalent | | Cables<br>Material | ABS - plastic<br>injection | ABS - plastic<br>injection | ABS - wire jacket | Equivalent | | Interface<br>with Patient | Around the<br>abdomen or<br>thorax belts<br>using velcro<br>tapes | Around the<br>abdomen or thorax<br>belts using velcro<br>tapes | Around the<br>abdomen or thorax<br>belts using velcro<br>tapes | Identical | | Type of<br>Equipment to<br>Be Connected<br>to | Polysomnography<br>recorder | NA | Polysomnography<br>recorder | Identical | | Connector<br>Type | Monopolar DIN<br>42-802 touch<br>proof | NA | Monopolar DIN 42-<br>802 touch proof | Identical | | Signals<br>output | Body position:<br>upright, supine,<br>prone, left and<br>right<br>0 to 1 VDC<br>output | Body position:<br>upright, supine,<br>prone, left and<br>right<br>0 to 1 VDC output | Body position:<br>upright, supine,<br>prone, left and<br>right<br>0 to 1 VDC output | Identical | | Position<br>Detection<br>Technology | Combination of<br>electronic tilt<br>switches<br>generates<br>different types of<br>signals<br>depending on the<br>sensor position. | Combination of<br>electronic tilt<br>switches generates<br>different types of<br>signals depending<br>on the sensor<br>position. | Combination of<br>electronic tilt<br>switches generates<br>different types of<br>signals depending<br>on the sensor<br>position. | Identical | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Neurovirtual. The logo features a stylized waveform graphic in shades of orange on the left. To the right of the waveform is the company name "NEUROVIRTUAL" in blue, with the "O" in Neurovirtual being a solid orange circle. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform in shades of yellow and orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in "NEUROVIRTUAL" is colored orange, matching the waveform. | Power Source | 3VDC coin<br>battery | AA batteries | 3VDC coin battery | Similar | |-------------------------|------------------------------------------------|------------------------------|--------------------------------|------------| | Applicable<br>Standards | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | Identical | | Packing | Plastic bag | Cartoon box | Plastic bag | Equivalent | | Sensor<br>Dimensions | 39x31x15 mm | NA | 40x29x14 mm | Equivalent | | Device<br>Picture | Image: Device with black strap and white wires | Image: BW device | Image: Device with black strap | Equivalent | Substantial Equivalency Discussion: The Maxxi Position and the predicate devices BWMini and Ultima Body Position Sensor are substantially equivalent in technology, function, and intended use: the devices are intended to provide body position signals for sleep disordered studies; the devices use the same method of action; the devices use equivalent material and also provide identical output signals. ### I) Performance Testing Summary: ### 1. Electrical Safety and Effectiveness Testing The Maxxi Position was submitted to standard IEC 60601-1 test which resulted in full compliance as reported in the test reports. #### 2. EMC Testing The Maxxi Position was submitted to electromagnetic compatibility test, standard IEC 60601-1-2 which resulted in full compliance as reported in the test reports. #### 3. Signal Quality and Comparison Testing: Signal integrity tests were conducted for the Maxxi Position Sensor with focus on signal to noise ratio, signal range, bandwidth and linearity and the test results compared to the signal integrity test conducted for the predicate Ultima Body Position Sensor. #### 4. Performance Testing: The performance test was conducted in order to verify technological and functional performance characteristics when compared with the predicate. The summary of the results is listed below. | Performance<br>Test | Description | Acceptance Criteria<br>(Predicate Specs) | Maxxi Position<br>Results | |----------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------| | Sensor<br>Dimensions | Verify if the dimensions of the<br>sensor are within the acceptable<br>range in accordance with the<br>product specifications. | 40x29x14 mm<br>Allowance: +-10% | Measured Value:<br>39x31x15 mm<br>Pass ( x ) Fail ( ) | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in Neurovirtual is replaced with an orange circle. The logo is simple and modern, and it is likely used to represent a company or organization that is involved in neuroscience or virtual reality. | Cable<br>Dimensions | Verify if the cable length is within<br>the acceptable range. | Cable length: 7ft<br>Allowance: +-5% | Measured Value: 7ft<br>Pass ( x ) Fail ( ) | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Cable<br>Connectivity | Using a multimeter in continuity<br>scale, check if the internal belt<br>wiring has connectivity. | Not allowed false<br>contact, or no<br>connectivity. | Pass ( x ) Fail ( ) | | Sensor<br>Visual<br>Aspects | Verify the visual aspects of the<br>product including, labeling,<br>mechanism of action, method of<br>connection, application,<br>interaction with the user and<br>cable specifications. | The visual aspects of<br>the Maxxi Position<br>must be<br>similar/equivalent to<br>the predicate device<br>Ultima Body Position<br>Sensor. | Pass ( x ) Fail ( ) | | Sensor<br>Signal<br>Aspect | Signal integrity tests were<br>conducted for the Maxxi Position<br>Sensor with focus on signal to<br>noise ratio, signal range,<br>bandwidth and linearity and the<br>test results compared to the<br>signal integrity test conducted<br>for the predicate Ultima Body<br>Position Sensor. | Qualitative signal<br>analysis must be<br>similar in signal type,<br>amplitude and<br>linearity when<br>compared with the<br>predicate device<br>Ultima Body Position<br>Sensor. | Pass ( x ) Fail ( ) | | Sensor<br>Functional<br>Aspect | Verify if the PSG system<br>identifies the sensor's position<br>Supine, Prone, Left, Right and<br>Stand accordingly with the<br>respective sensor output signals. | All positions signal<br>shown in the user<br>manual must follow<br>the patient body<br>position based on the<br>sensor axis position | Pass ( x ) Fail ( ) | #### 5. Performance Testing in Simulated Use: A comparative test in simulated use was performed in N=20 volunteers in a simulated use study between the subject device and predicates in order to compare the accuracy and latency to detect the patient's body position in a PSG system. The results showed the average time to detect the patient body position was 1 second of latency difference between the devices and 100% of accuracy between them. This result demonstrated substantially equivalence between the subject device and the predicates. Based on the substantial equivalence comparison, and nonclinical Conclusion: performance tests applied to the Maxxi Position Sensor and the predicates, we conclude that the devices have similar indications for use, technological characteristics and method of action, additionally the nonclinical performance testing demonstrate that the subject device is safe and effectively as well substantially equivalency to the predicates. ## J) Clinical Testing: No clinical trial was performed.